Monitoring System for Cranial Orthoses

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06425172
Status
Recruiting
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Conditions

  • Brachycephaly
  • Deformational Plagiocephaly
  • Deformational Posterior Plagiocephaly
  • Plagiocephaly

Eligibility Criteria

Sex
ALL
Age
3 Months - 18 Months
Healthy Volunteers
Not accepted

Interventions

  • Cranial Remolding Orthosis — DEVICE
    A custom made FDA-approved cranial remolding orthosis will be retrofit with sensors used in the research.

Study Details

This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).

Key Dates

Start date
Aug 19, 2024
Status verified
Jul 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
12 participants (estimated)

Arms

  • Arm: Infants with with deformational head shapes
    Infants who have been referred for custom orthotic treatment for a deformational head shape such as deformational plagiocephaly or deformational brachycephaly.

Primary Outcome Measure

Wear time monitoring and validation [ Time Frame: Data will be recorded for 8-9 weeks per subject, and analyzed throughout the study. Anticipated to be complete on all subjects within 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Tiffany Graham

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By research site
UT Southwestern Medical Center· Dallas, TX

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